SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract.
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: gemcitabine hydrochloride Drug: lonafarnib||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997|
|Study Start Date:||June 2000|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
- Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract.
- Determine the time to progression and objective response rate of this treatment regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral SCH 66336 twice a day (starting on day 2 of the first course, and starting on day 1 of all subsequent courses). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 7-31 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006351
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, 6500|
|Study Chair:||Ronald De Wit, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Study Chair:||Pieter H. M. de Mulder, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|
|Study Chair:||Godefridus Peters, PhD||Free University Medical Center|